Home / Obligation register / device-data

F2025L00414, Sch 1 item 6, reg 13C.3(1) to (3)

Enter the 17 device data elements

The sponsor or manufacturer responsible for the device, in practice. The clause is passive and does not name the party that lodges the entry. Seventeen categories of device information must be in the database for a UDI device, entered before the end of 30 days starting on the first supply day on or after the general start day.

Reader note for unit 13: this provision sits in Schedule 1, under The database. The first action it calls for is to build the 17-field template. The evidence it names first is a completed field checklist with a value or an explicit not applicable for each of the 17. The provision read on this page is Sch 1 item 6, reg 13C.3(1) to (3). It is unit 13 of 21 in the register.

Key date: 1 April 2028. Schedule 2 Part 2 commences and widens adverse event reporting to Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices. The UDI amendments commenced on 25 March 2025 and apply from each device general start day. The full date table.

What the provision requires

Seventeen categories of device information must be in the database for a UDI device, entered before the end of 30 days starting on the first supply day on or after the general start day. The categories run from the manufacturer TGA number and name to handling, warnings, instructions, single-use status, sterilisation, batch and serial flags, date flags, blood donation flag, software flag, kit flag and base package quantity. If the clinical size type is held, the value and unit must also be entered.

Source pointer: reg 13C.3(1)-(3).

What it means in practice

The clause sets the content of a usable device record. It ties the content deadline to the same 30-day window as the identifier.

The list is specific and should be treated as a field checklist, not a narrative description. Several fields are flags rather than values, so a blank is not the same as a no. The clinical size rule is conditional on the database holding the type.

Source pointer: reg 13C.3(1)-(3).

Evidence to keep

An auditor or a regulator will ask for the record that shows the duty was met, not a description of the process. Keep these artefacts with the device or facility file.

A completed field checklist with a value or an explicit not applicable for each of the 17. The clause lists the categories.
The label and ARTG source for each value. The record must match the device.
A data-quality check before submission. A blank flag is a missing entry, not a negative answer.

Source pointer: reg 13C.3(1)-(2). The artefacts are our suggested evidence, not a form prescribed by the instrument.

Common gaps

Leaving flags blank.
Copying a brand name that differs from the label.
No clinical size value where the type is held.
A kit record with no base package quantity.

Preparation steps

Build the 17-field template.
Assign a source document to each field.
Run a peer check before submission.

Dates that matter for this unit

Date	What happens	Note
2026-07-01	Earliest general start day	dictionary, general start day

Source pointer: reg 13C.3(3).

Where it sits

Identifier entry, reg 13C.2.
Accuracy duty, reg 13C.4.
Clinical size definition, reg 13C.3(2).

Questions this provision raises

Is the list a minimum or a complete set?

The clause says the following information must be included, so treat the list as the required set. A field that does not apply should still be recorded as not applicable rather than left blank.

Are all 17 fields required for every device?

The categories are required, but several are conditional in substance: a sterilisation method only if applicable, and a clinical size value only where the database holds the type. The condition should be recorded, not guessed.

What is the base package quantity?

It applies where the device is intended to be packaged together with UDI devices of the same model. The clause asks for the number of devices intended to be in the base package. It is not a general pack size field.

Source pointer for the page

Citation: Sch 1 item 6, reg 13C.3(1) to (3)
Instrument: Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 (F2025L00414)
Official text: https://www.legislation.gov.au/F2025L00414/latest/text
Binding party: reg 13C.3(1)-(2)
Requirement: reg 13C.3(1)-(3)
Evidence: reg 13C.3(1)-(2)
Dates: reg 13C.3(3)
Silent fields: Where the instrument does not state a form, a period or a frequency, this page says so rather than filling the gap.

Back to the register. Next: Keep every entry accurate and current.